Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-026)

This is a non-inferiority study comparing MK-3102 with Sitagliptin in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. The primary hypothesis is that after 24 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with MK-3102 is non-inferior to that in participants treated with sitagliptin. There will be a 2-week run-in period with placebo + metformin prior to the double-blind treatment period.

A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

Glimepiride tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy

Other Names:

Amaryl®

Glimy

Active Comparator: Sitagliptin + metformin

100 mg tablet once a day for 24 weeks

Drug: Sitagliptin

Sitagliptin - 100 mg tablet once a day for 24 weeks

Drug: Placebo to MK-3102

Placebo once a week for 24 weeks

Drug: Open-label Metformin

Tablet(s) total daily dose of ≥1500 mg, once or twice a day

Other Names:

Fortamet®

Glucophage®

Glucophage® XR

Glumetza®

Riomet®

Drug: Open-label Glimepiride

Glimepiride tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy

Other Names:

Amaryl®

Glimy

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Type 2 diabetes mellitus

Currently on a stable dose of metformin monotherapy (≥1500 mg per day) for at least 12 weeks prior to study participation

Male, or female who is not of reproductive potential or if of reproductive potential agrees to abstain from heterosexual activity or use (or have their partner use) acceptable contraception to prevent pregnancy during the study and for 21 days after the last dose of study drug

Exclusion Criteria:

History of type 1 diabetes mellitus or a history of ketoacidosis

Has been treated with any antihyperglycemic agent (AHA) other than the protocol-required metformin within 12 weeks prior to study participation or with MK-3102 at any time prior to signing informed consent

History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor

Is currently participating in, or has participated in, a trial in which the participant received an investigational compound or used an investigational device within the prior 12 weeks of signing the informed consent or is not willing to refrain from participating in any other trial

History of intolerance, hypersensitivity, or any other contraindication to metformin or glimepiride

Is on a weight loss program and is not in the maintenance phase or has been on a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation

Has undergone a surgical procedure within 4 weeks of study participation or has planned major surgery during the study

Is on or likely to require treatment ≥14 consecutive days or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)

Currently being treated for hyperthyroidism or is on thyroid hormone replacement therapy and has not been on a stable dose for at least 6 weeks

Is expecting to undergo hormonal therapy in preparation to donate eggs during the period of the trial, including 21 days after the last dose of trial medication

Pregnant or breastfeeding, or is expecting to conceive during the study including 21 days following the last dose of blinded study drug

User of recreational or illicit drugs or has had a recent history of drug abuse

Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking

Has donated blood products or has had phlebotomy of >300 mL within 8 weeks of study participation, or intends to donate blood products within the projected duration of the trial or has received, or is anticipated to receive, blood products within 12 weeks of study participation or within the projected duration of the trial

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.